Molecular risk prediction in cutaneous melanoma: a meta-analysis of the 31-gene expression profile prognostic test in 1,479 patients.

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Multiple studies have reported on the accuracy of the prognostic 31-gene expression profile test (31-GEP) for cutaneous melanoma. Consistency of the test results across studies has not been systematically evaluated.To assess the robustness of the prognostic value of the 31-GEP.Raw data were obtained from studies identified from systematic review. A meta-analysis was performed to determine overall effect of the 31-GEP. Clinical outcome metrics for the 31-GEP were compared to AJCC staging.Three studies met inclusion criteria; data from a novel cohort of 211 patients were included (n=1,479). Five-year recurrence-free and distant metastasis-free survival (DMFS) rates were 91.4% and 94.1% for Class 1A patients and 43.6% and 55.5% for Class 2B patients (p<0.0001). Meta-analysis results show that Class 2 was significantly associated with recurrence (HR: 2.90; p<0.0001) and distant metastasis (HR: 2.75; p<0.0001). The 31-GEP identified AJCC stage I-III patient subsets with high likelihood for recurrence and distant metastasis. Sensitivity was 76% [95%CI 71-80%] and 76% [95%CI 70-82%] for each endpoint, respectively. When 31-GEP and sentinel lymph node biopsy results were considered together, sensitivity and negative predictive value for DMFS were both improved.The 31-GEP test consistently and accurately identifies melanoma patients at increased risk of metastasis, is independent of other clinicopathologic covariates, and augments current risk stratification by re-classifying patients previously designated as low risk, for heightened surveillance.

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